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Voyager Therapeutics Reports Fourth Quarter and Full Year 2023 Financial and Operating Results

- Company had approximately $431 million in pro-forma cash as of December 31, 2023, adjusted for $100 million consideration from Novartis agreements and $100 million public offering -

- Strong cash position and anticipated milestones/reimbursements provide runway into 2027, potentially enabling the generation of clinical data from multiple programs -

- Lead development candidates selected in Friedreich’s ataxia gene therapy program in collaboration with Neurocrine Biosciences, triggering $5 million milestone payment, and in wholly-owned SOD1 ALS gene therapy program -

- Conference call at 4:30 p.m. ET today -

LEXINGTON, Mass., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today reported fourth quarter and full year 2023 financial and operating results.

“As of December 31, 2023, Voyager had approximately $431 million in pro-forma cash on the balance sheet, adjusted for the Novartis agreements and public offering in January 2024. We expect this funding to support the generation of clinical data across multiple programs, with the potential for significant value creation,” said Alfred W. Sandrock, Jr., M.D., Ph.D., Chief Executive Officer of Voyager. “We expect to advance at least four wholly-owned and partnered programs into the clinic by the end of next year. Our most advanced program, the anti-tau antibody VY-TAU01 for Alzheimer’s disease, is expected to reach IND in the first half of this year, and we anticipate generating key tau PET imaging data in the second half of 2026.”

Key Milestones Achieved in Q4 2023 and Subsequent Period:

• Strategic collaboration and capsid license agreement with Novartis: In December 2023, Voyager entered into a strategic collaboration and capsid license agreement with Novartis Pharma AG to advance potential gene therapies for Huntington’s disease (HD) and spinal muscular atrophy (SMA). Novartis agreed to pay Voyager $80 million of consideration up front and $20 million for the purchase of newly issued equity in Voyager. Voyager is eligible to receive up to $1.2 billion in preclinical, development, regulatory and sales milestones, as well as tiered royalties on global net sales of products incorporating Voyager’s TRACER™ capsids.
• Completion of public offering: In January 2024, Voyager completed an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) for aggregate gross proceeds of approximately $100 million.
• Selection of development candidate for SOD1 ALS gene therapy program: In December 2023, Voyager announced it selected a lead development candidate for its superoxide dismutase 1 (SOD1)-mutated amyotrophic lateral sclerosis (ALS) gene therapy program. The Company expects to file an IND for this candidate in mid-2025.
• Selection of development candidate for Neurocrine-partnered Friedreich’s ataxia gene therapy program: In February 2024, Voyager announced that the joint steering committee with its collaborator Neurocrine Biosciences selected a lead development candidate for the frataxin (FXN) gene therapy program for Friedreich’s ataxia, which triggered a $5 million milestone payment to Voyager. The companies expect the program to enter the clinic in 2025.
• Tau silencing gene therapy program for Alzheimer’s disease prioritized following in vivo proof-of-concept: In February 2024, Voyager announced that a single intravenous administration of its tau silencing gene therapy in mice expressing human tau resulted in broad AAV distribution across multiple brain regions and dose-dependent reductions in tau messenger RNA (mRNA) levels of up to 90%, which were associated with robust reductions in human tau protein levels across the brain. The data will be presented at the upcoming 2024 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD™ 2024). Voyager has promoted the program to a prioritized program within its wholly-owned pipeline and anticipates filing an IND in 2026.

Key Upcoming Milestones:

• VY-TAU01 anti-tau antibody for Alzheimer’s disease: Voyager expects to file an IND in first half of 2024, initiate a Phase 1a single ascending dose study in healthy volunteers in 2024, and initiate a Phase 1b multiple ascending dose study in patients with early Alzheimer’s disease in 2025. This study has the potential to generate proof-of-concept data for slowing the spread of pathological tau via tau PET imaging in 2026.
• SOD1 silencing gene therapy program for ALS: Voyager expects to file an IND in mid-2025 and initiate a Phase 1 clinical trial in ALS patients, laying the foundation to potentially generate proof-of-concept based on validated biomarkers.
• Partnered programs: Voyager expects that its collaborative partners and licensees will submit at least two IND applications for partnered programs in Voyager’s pipeline and initiate clinical development for the associated programs by the end of 2025, including the FXN gene therapy program for Friedreich’s ataxia partnered with Neurocrine Biosciences.

Fourth Quarter 2023 Financial Results

• Collaboration Revenues: Voyager had collaboration revenue of $90.1 million for the fourth quarter of 2023, compared to $(1.6) million for the same period in 2022. The increase was primarily due to $80.0 million in collaboration revenue recognized during the fourth quarter of 2023 in connection with the 2023 Novartis collaboration agreement, $5.3 million of revenue associated with the 2023 Neurocrine collaboration agreement, $4.6 million of revenue associated with the 2019 Neurocrine collaboration agreement, and $0.2 million of other collaboration revenue.
• Net Income (Loss): Net income was $56.4 million for the fourth quarter of 2023, compared to net loss of $23.6 million for the same period in 2022. The difference is primarily due to the increase in collaboration revenue discussed above.
• R&D Expenses: Research and development expenses were $25.8 million for the fourth quarter of 2023, compared to $14.6 million for the same period in 2022. The increase in R&D expenses was primarily a result of increased program-related spending, particularly manufacturing and IND-enabling studies for the anti-tau antibody program and SOD1 program, along with increased Neurocrine program support, during the fourth quarter of 2023.
• G&A Expenses: General and administrative expenses were $10.2 million for the fourth quarter of 2023, compared to $8.5 million for the same period in 2022. The increase in G&A expenses was primarily a result of $1.9 million of business development costs related to the 2023 Novartis collaboration agreement recognized in the fourth quarter of 2023.
• Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2023, were $230.9 million. Cash position does not include proceeds received from the 2023 Novartis agreements and our underwritten public offering, both of which were received after December 31, 2023.

Full Year 2023 Financial Results

• Collaboration Revenues: Voyager had collaboration revenue of $250.0 million for the year ended December 31, 2023, compared to $40.9 million for the same period in 2022. The increase in collaboration revenue was the result of $79.0 million in revenue recognized during the year ended December 31, 2023, in connection with Novartis’ decision to exercise two of its license options under the 2022 Novartis option and license agreement, along with the expiration of a third Novartis license option. In addition, during the year ended December 31, 2023, Voyager recognized $80.0 million of revenue associated with the 2023 Novartis collaboration agreement, $80.8 million of revenue associated with the 2023 Neurocrine collaboration agreement, $9.8 million of revenue associated with the 2019 Neurocrine collaboration agreement, and $0.4 million of other collaboration revenue. During the year ended December 31, 2022, collaboration revenue was primarily related to Pfizer’s decision, as Alexion’s predecessor in interest under the Alexion option and license agreement, to exercise the first license option along with the expiration of the second license option, which resulted in revenue recognized of $40.0 million.
• Net Income (Loss): Net income was $132.3 million for the year ended December 31, 2023, compared to net loss of $46.4 million for the same period in 2022. The difference was primarily due to the revenue increases noted above.
• R&D Expenses: Research and development expenses were $92.2 million for the year ended December 31, 2023, compared to $60.8 million for the same period in 2022. The increase in R&D expenses was primarily a result of increased program-related spending, particularly manufacturing and IND-enabling studies for the anti-tau antibody program and SOD1 program, along with increased Neurocrine program support, during the 2023 period. The increase was also a result of increased compensation costs driven by headcount increases, including targeted development team hires to support the advancing pipeline, during the 2023 period.
• G&A Expenses: General and administrative expenses were $35.8 million for the year ended December 31, 2023, compared to $31.0 million for the same period in 2022. The increase in G&A expenses was primarily a result of increased compensation costs driven by headcount increases, as well as $1.9 million of business development costs related to the 2023 Novartis agreements recognized in the fourth quarter of 2023.

Financial Guidance Voyager is committed to maintaining a strong balance sheet that supports the advancement and growth of its platform and pipeline. Voyager continues to assess its planned cash needs both during the current period and in future periods. We expect our cash, cash equivalents, and marketable securities including the cash received from the Novartis Collaboration and Licensing Agreement and Stock Purchase Agreement, and the completion of the public offering in January, along with amounts expected to be received as reimbursement for development costs under the Neurocrine and Novartis collaborations, certain near-term milestones, and interest income, to be sufficient to meet Voyager’s planned operating expenses and capital expenditure requirements into 2027.

Conference Call Voyager will host a conference call and webcast today at 4:30 p.m. ET to discuss the fourth quarter and full year 2023 financial and operating results. To participate via telephone and join the call live, please register in advance here: https://register.vevent.com/register/BIe93582a25c24475387f933ce1c5337e3 . Upon registration, telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a unique passcode. A live webcast of the call will also be available on the Investors section of the Voyager website at ir.voyagertherapeutics.com, and a replay of the call will be available at the same link approximately two hours after its completion. The replay will be available for at least 30 days following the conclusion of the call.

About the TRACER™ Capsid Discovery Platform Voyager’s TRACER™ (Tropism Redirection of AAV by Cell-type-specific Expression of RNA) capsid discovery platform is a broadly applicable, RNA-based screening platform that enables rapid discovery of AAV capsids with robust penetration of the blood-brain barrier and enhanced central nervous system (CNS) tropism in multiple species, including non-human primates (NHPs). In preclinical studies, TRACER generated capsids have demonstrated widespread gene expression in the CNS compared to conventional AAV capsids as well as cell- and tissue-specific transduction, including to areas of the brain that have been traditionally difficult to reach, while de-targeting the liver and dorsal root ganglia. As part of its external partnership strategy, Voyager has established multiple collaboration agreements providing access to its next-generation TRACER capsids to potentially enable its partners’ gene therapy programs to treat a variety of diseases.

About Voyager Therapeutics Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit  www.voyagertherapeutics.com .

Voyager Therapeutics ® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc. 

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “expect,” “will,” “believe,” “anticipate,” “potential,” “trigger” or “continue,” and other similar expressions are intended to identify forward-looking statements.

For example, all statements Voyager makes regarding Voyager’s ability to advance its AAV-based gene therapy programs and tau antibody program, including expectations for Voyager’s achievement of preclinical and clinical development milestones for its potential development candidates such as IND filings, the initiation of clinical trials, and generation of proof-of-concept; Voyager’s ability to advance gene therapy product candidates under the Neurocrine and Novartis collaborations; Voyager’s anticipated financial results, including the anticipated receipt by Voyager of revenues or reimbursement payments from collaboration partners; and Voyager’s cash runway and ability to generate sufficient cash resources to enable it to continue its business and operations are forward looking.

All forward-looking statements are based on estimates and assumptions by Voyager’s management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, the continued development of Voyager’s technology platforms, including Voyager’s TRACER platform and its antibody screening technology; the ability to initiate and conduct preclinical studies in animal models; the development by third parties of capsid identification platforms that may be competitive to Voyager’s TRACER capsid discovery platform; Voyager’s ability to create and protect intellectual property rights associated with the TRACER capsid discovery platform, the capsids identified by the platform, and development candidates for Voyager’s pipeline programs; the initiation, timing, conduct and outcomes of Voyager’s preclinical and clinical studies; the possibility or the timing of Voyager’s receipt of program reimbursement, development or commercialization milestones, option exercise, and other payments under Voyager’s existing licensing or collaboration agreements; the ability of Voyager to negotiate and complete licensing or collaboration agreements with other parties on terms acceptable to Voyager and the third parties; the ability to attract and retain talented directors, employees, and contractors; and the sufficiency of cash resources to fund its operations and pursue its corporate objectives.

These statements are also subject to a number of material risks and uncertainties that are described in Voyager’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Contacts Trista Morrison, NACD.DC, [email protected] Investors: Adam Bero, Ph.D., [email protected] Media: Brooke Shenkin, [email protected]

GAAP vs. Non-GAAP Financial Measures Voyager’s financial statements are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent revenue and expenses as reported to the Securities and Exchange Commission. Voyager has provided in this release certain financial information that has not been prepared in accordance with GAAP, including pro-forma cash, and net collaboration revenue and net research and development expenses, the latter two of which exclude the impact of reimbursement by Neurocrine Biosciences (Neurocrine) for expenses we incur in conducting preclinical development activities under our collaboration agreements. Management uses these non-GAAP measures to evaluate the Company’s operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in its business. Management believes that such non-GAAP measures are important in comparing current results with prior period results and are useful to investors and financial analysts in assessing the Company’s operating performance. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation. The non-GAAP measures give investors and financial analysts a better understanding of our net revenue and net research and development expenses without the pass-through impact of Neurocrine costs. The non-GAAP financial information presented here should be considered in conjunction with, and not as a substitute for, the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP financial measures set forth below.

The Company’s pro-forma cash as of December 31, 2023, was $431 million which includes $230.9 million of cash, cash equivalents, and marketable securities as of December 31, 2023, as adjusted for the gross proceeds received from the 2023 Novartis collaboration agreement and our underwritten public offering in January 2024. This does not include any costs associated with executing the Novartis collaboration or the public offering.

Note 1: Under the Company's existing collaboration agreements with Neurocrine, Neurocrine has agreed to be responsible for all costs the Company incurs in conducting preclinical development activities for each Neurocrine collaboration program, in accordance with joint steering committee agreed upon workplans and budgets. Reimbursable research and development services performed during the period are captured within collaboration revenue and research and development expenses in the Company's consolidated statements of operations. During the three and twelve months ended December 31, 2023, we incurred $3.1 million and $10.1 million, respectively, of reimbursable research and development services recorded within collaboration revenue and research and development expenses. During the three and twelve months ended December 31, 2022, we incurred $0.3 million and $0.8 million, respectively, of reimbursable research and development services recorded within collaboration revenue and research and development expenses.

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• Alzheimer’s early research

• SOD1 for ALS

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Latest News

Voyager Therapeutics to Present Broad Set of Translational Data Supporting...

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Voyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases.

Advancing transformative medicines for neurological diseases.

Our pipeline includes genetic medicines for Alzheimer’s disease , amyotrophic lateral sclerosis (ALS) , Parkinson’s disease , and multiple other diseases of the central nervous system.

Revolutionizing delivery across the blood-brain barrier.

Our people are our most valuable resource.

We are looking for dedicated professionals who share our passion for advancing transformative neurogenetic medicines.

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• News for Voyager Therapeutics

Oppenheimer Sticks to Their Buy Rating for Voyager Therapeutics (VYGR)

In a report released today, Jay Olson from Oppenheimer maintained a Buy rating on Voyager Therapeutics ( VYGR – Research Report ), with a price target of $18.00 . The company’s shares closed yesterday at $7.82.

Olson covers the Healthcare sector, focusing on stocks such as Biogen, Incyte, and Ionis Pharmaceuticals. According to TipRanks , Olson has an average return of 17.6% and a 42.71% success rate on recommended stocks.

Currently, the analyst consensus on Voyager Therapeutics is a Strong Buy with an average price target of $18.75, which is a 139.77% upside from current levels. In a report released on April 16, Wells Fargo also maintained a Buy rating on the stock with a $14.00 price target.

Based on Voyager Therapeutics’ latest earnings release for the quarter ending December 31, the company reported a quarterly revenue of $90.06 million and a net profit of $56.4 million. In comparison, last year the company had a GAAP net loss of $23.63 million

Based on the recent corporate insider activity of 19 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of VYGR in relation to earlier this year.

TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which 3 stocks are most likely to make moves following their insider activities.

Voyager Therapeutics (VYGR) Company Description:

Voyager Therapeutics, Inc. operates as a clinical-stage gene therapy company, which develops treatments for patients suffering from central nervous system. Its pipeline of gene theraphy programs include VY-AADC, VY-SOD101, VY-HTT01, VY-FXN01, Tau Program, and VY-NAV01. The company was founded by Guangping Gao, Mark A. Kay, Krystof Bankiewicz and Phillip Zamore in June 2013 and is headquartered in Cambridge, MA.

Read More on VYGR:

• Voyager Therapeutics to Present Broad Set of Translational Data Supporting IV-Delivered, CNS Gene Therapy Programs Advancing Toward Clinical Trials at the ASGCT 27th Annual Meeting
• Voyager announces selection of development candidate for GBA1 Program
• Voyager Therapeutics Announces Selection of Development Candidate for GBA1 Program in Collaboration with Neurocrine Biosciences, Triggering Milestone Payment
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Bicycle Therapeutics advances drugs pipeline and extends cash runway into 2026

The company ended Q1 with cash and equivalents of $457 million and reported continued progress across its R & D pipeline with numerous clinical data readouts and updates expected in the second half of 2024.

The company is pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology.

CEO Kevin Lee praised the company’s laser focus on its technology. He said: “During the first quarter, we focused on execution across all aspects of our business. We were pleased to initiate our Phase 2/3 Duravelo-2 registrational trial for BT8009 in metastatic urothelial cancer, and we are actively working on patient enrolment and site activation.

“We continue to make progress across the rest of our pipeline of differentiated, precision-guided therapeutic candidates and look forward to a catalyst-rich second half of the year.”

He congratulated Mike Hannay on his promotion to Chief Product and Supply Chain Officer, adding: “Since joining the company two years ago, he has significantly advanced our manufacturing capabilities and priorities and I look forward to seeing him excel in this new position.”

Over the course of his career, through his work at Sanofi, Schwarz Pharma, Teva Pharmaceuticals and AstraZeneca, Professor Hannay has launched more than 40 medicines.

Two Bicycle abstracts have been accepted for poster presentation at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago from May 31 to June 4. These highlight the company’s clinical progress in developing Bicycle Toxin Conjugates® (BTC® molecules) as differentiated cancer therapies.

The first abstract will examine the clinical pharmacokinetics and safety of BTC molecules, while the second will outline the company’s ongoing Phase 2/3 clinical trial, called Duravelo-2, of BT8009 in metastatic urothelial cancer (mUC).

Three posters were presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego last month. Bicycle shared preclinical data showcasing its work to develop BTC molecules for the treatment of solid tumours, Natural Killer Tumour-Targeted Immune Cell Agonist (NK-TICA®) molecules that can engage NK cells to directly kill malignant tumour cells and Bicycle Tumour-Targeted Immune Cell Agonist® (Bicycle TICA®) molecules that can activate the body’s immune system to enable tumour rejection.

Altogether, the posters underscore the breadth of the company’s platform technology and its capabilities to produce different modalities to target cancer.

Bicycle reports continued progress across its R & D pipeline, with numerous clinical data readouts and program updates expected in 2H 2024. Importantly, Bicycle initiated the Phase 2/3 Duravelo-2 registrational trial for BT8009 in mUC, and patient enrolment is ongoing.

The company continues to assess BT8009, BT5528 and BT7480 in Phase 1/2 clinical trials across a variety of tumour types and plans to provide updates from its wholly owned Bicycle® Radio Conjugate (BRC™) pipeline.

Q1 cash and equivalents at $457m compared to $526.4m at the end of December. The fall was primarily due to cash used in operating activities, including upfront payments associated with the initiation of the company’s Phase 2/3 Duravelo-2 registrational trial.

R & D expenses were $34.9m compared to $32.2m in the same quarter of 2023. The modest rise was primarily due to increased clinical program expenses for BT8009 development and increased personnel-related expenses.

These were largely offset by decreased clinical program expenses for Bicycle TICA® molecule development and BT5528 development, as well as $8.2m of one-time, incremental retroactive UK R & D tax credits.

The Q1 net loss was significantly down year-on-year from $39.1m to $26.6m.

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Russia’s BN-800 refuelled with mox: full mox core planned for 2022

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The first full refuelling of Russia’s BN-800 fast reactor at unit 4 of the Beloyarsk NPP with only uranium-plutonium mixed oxide (mox) fuel was completed during the recent scheduled maintenance outage, fuel company TVEL (part of Rosatom) announced on 24 February. The unit, which was shut down on 8 January, has been reconnected to the grid and has resumed electricity production. The first 18 serial mox fuel assemblies were loaded into the reactor in January 2020, and another 160 fuel assemblies have now been added to them. Thus, the BN-800 core is now one-third filled with innovative fuel and in future only mox fuel will be loaded into the reactor.

“Beloyarsk NPP is now one step closer to implementation of the strategic direction for the development of the nuclear industry - the creation of a new technological platform based on a closed nuclear fuel cycle,” said Ivan Sidorov, Director of the Beloyarsk NPP. “The use of mox fuel will make it possible to involve in fuel manufacture the isotope of uranium that is not currently used. This will increase the fuel base of the nuclear power industry tenfold. In addition, the BN-800 reactor can reuse used nuclear fuel from other NPPs and minimise radioactive waste by “afterburning” long-lived isotopes from them. Taking into account the planned schedule, we will be able to switch to a core with a full load of mox fuel in 2022.”

The fuel assemblies were manufactured at the Mining and Chemical Combine (MCC, Zheleznogorsk, Krasnoyarsk Territory). Unlike enriched uranium, which is traditional for nuclear power, the raw materials for the production of mox fuel pellets are plutonium oxide produced in power reactors and depleted uranium oxide (obtained by defluorination of depleted uranium hexafluoride - DUHF, the secondary "tailings" of the enrichment plant.

“In parallel with loading the BN-800 core with mox fuel, Rosatom specialists are continuing to develop technologies for the production of such fuel at the MCC,” said Alexander Ugryumov, vice president for research, development and quality at TVEL. “In particular, the production of fresh fuel using high-background plutonium extracted from the irradiated fuel of VVER reactors has been mastered: all technological operations are fully automated and are performed without the presence of personnel in the immediate vicinity. The first 20 mox-FAs incorporating high-background plutonium have already been manufactured and passed acceptance tests, and they are planned to be loaded in 2022. Advanced technologies for recycling nuclear materials and refabrication of nuclear fuel in the future will make it possible to process irradiated fuel instead of storing it, as well as to reduce the amount of high-level waste generated.”

Serial production of mox fuel began at the end of 2018 at MCC. To achieve this, broad industry cooperation was organised under the coordination and scientific leadership of TVEL, which supplies the mox-fuel to Beloyarsk NPP. Initially, the BN-800 reactor was launched with a hybrid core, partly equipped with uranium fuel produced by Mashinostroitelny Zavod in Elektrostal (Moscow Region), and partly with experimental mox assemblies manufactured at the Research Institute of Atomic Reactors (NIIAR) in Dimitrovgrad, Ulyanovsk region).

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Leonid Mikhelson and Gennady Timchenko choked on gas

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The company of “Putin’s friends” easily earns billions of euros from Austria.

The wife of the head of the Russian Gazprombank Akimov does not leave the USA and Europe

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European companies bypassed sanctions against Russia

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Leonid Mikhelson and Gennady Timchenko emitted liquefied gas

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A court in the USA ruled in favor of a Russian oligarch Stanislav Kondrashov

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Abramovich hid from sanctions behind his children

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In Monaco, the criminal case against the scandalous Russian oligarch was closed.

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A new package of EU sanctions against Russia will allow the Helsinki Hall arena in Helsinki to be seized at half price from the odious oligarchs Arkady and Boris Rotenberg, as well as Gennady Timchenko.

Russian oligarch Kondrashov, who sponsors Putin’s war against Ukraine, closes objectionable sites

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Vladimir Putin's eighth yacht was found

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Here's why we're not too worried about thiogenesis therapeutics' (cve:tti) cash burn situation.

Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the right price. For example, although Amazon.com made losses for many years after listing, if you had bought and held the shares since 1999, you would have made a fortune. Nonetheless, only a fool would ignore the risk that a loss making company burns through its cash too quickly.

So should Thiogenesis Therapeutics ( CVE:TTI ) shareholders be worried about its cash burn? For the purpose of this article, we'll define cash burn as the amount of cash the company is spending each year to fund its growth (also called its negative free cash flow). The first step is to compare its cash burn with its cash reserves, to give us its 'cash runway'.

View our latest analysis for Thiogenesis Therapeutics

Does Thiogenesis Therapeutics Have A Long Cash Runway?

A company's cash runway is calculated by dividing its cash hoard by its cash burn. As at December 2023, Thiogenesis Therapeutics had cash of CA$7.1m and no debt. Importantly, its cash burn was CA$3.2m over the trailing twelve months. That means it had a cash runway of about 2.2 years as of December 2023. That's decent, giving the company a couple years to develop its business. You can see how its cash balance has changed over time in the image below.

How Is Thiogenesis Therapeutics' Cash Burn Changing Over Time?

Because Thiogenesis Therapeutics isn't currently generating revenue, we consider it an early-stage business. So while we can't look to sales to understand growth, we can look at how the cash burn is changing to understand how expenditure is trending over time. Over the last year its cash burn actually increased by a very significant 55%. While this spending increase is no doubt intended to drive growth, if the trend continues the company's cash runway will shrink very quickly. While the past is always worth studying, it is the future that matters most of all. For that reason, it makes a lot of sense to take a look at our analyst forecasts for the company .

How Hard Would It Be For Thiogenesis Therapeutics To Raise More Cash For Growth?

Given its cash burn trajectory, Thiogenesis Therapeutics shareholders may wish to consider how easily it could raise more cash, despite its solid cash runway. Issuing new shares, or taking on debt, are the most common ways for a listed company to raise more money for its business. Commonly, a business will sell new shares in itself to raise cash and drive growth. We can compare a company's cash burn to its market capitalisation to get a sense for how many new shares a company would have to issue to fund one year's operations.

Thiogenesis Therapeutics' cash burn of CA$3.2m is about 9.9% of its CA$33m market capitalisation. Given that is a rather small percentage, it would probably be really easy for the company to fund another year's growth by issuing some new shares to investors, or even by taking out a loan.

So, Should We Worry About Thiogenesis Therapeutics' Cash Burn?

Even though its increasing cash burn makes us a little nervous, we are compelled to mention that we thought Thiogenesis Therapeutics' cash runway was relatively promising. Based on the factors mentioned in this article, we think its cash burn situation warrants some attention from shareholders, but we don't think they should be worried. Taking a deeper dive, we've spotted 3 warning signs for Thiogenesis Therapeutics you should be aware of, and 1 of them can't be ignored.

Of course, you might find a fantastic investment by looking elsewhere. So take a peek at this free list of interesting companies, and this list of stocks growth stocks (according to analyst forecasts)

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Context Therapeutics Announces $100 Million Private Placement

Financing includes new and existing leading healthcare investors

Proceeds, along with existing cash and cash equivalents, are expected to extend cash runway into 2028

The private placement is led by new investor Nextech1, with participation from new and existing investors, including Ally Bridge Group, Avidity Partners, Blackstone Multi-Asset Investing, Blue Owl Healthcare Opportunities, Deep Track Capital, Driehaus Capital Management, Great Point Partners, LLC, and other leading healthcare investors.

Pursuant to the terms of the securities purchase agreement, Context is selling an aggregate of approximately 64.5 million shares of its common stock (or pre-funded warrants in lieu thereof) at a price of $1.55 per share (or $1.549 per pre-funded warrant). Each pre-funded warrant will have an exercise price of $0.001 per share of common stock, will be immediately exercisable and will not expire. The price per share of common stock and per pre-funded warrant represents a premium to the closing price of the Company’s common stock on May 1, 2024. Context expects that the net proceeds from the private placement, together with the Company’s existing cash and cash equivalents, will extend its cash runway through the estimated duration of the Company’s planned CTIM-76 Phase 1 clinical trial, as well as into 2028.

Piper Sandler is acting as sole placement agent for the private placement.

The offer and sale of the securities in the private placement and described above are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Pursuant to a registration rights agreement, Context agreed to file a registration statement with the Securities and Exchange Commission (the “SEC”) covering the resale of the shares of common stock issued in this private placement and the shares of common stock underlying the pre-funded warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

1 Nextech Invest Ltd, on behalf of one or more funds managed by it.

About Context Therapeutics ®

Forward-looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the expected gross proceeds from the private placement and intended use of net proceeds, (ii) our expectation to close the private placement on or about May 6, 2024, (iii) our expectation that the funds from the private placement, together with our existing cash and cash equivalents, will extend the Company’s cash runway through the estimated duration of the Company’s planned CTIM-76 Phase 1 clinical trial, as well as into 2028, (iv) the potential benefits, characteristics, safety and side effect profile of CTIM-76, (v) the ability of CTIM-76 to have benefits, characteristics, manufacturability, and a side effect profile that is differentiated and/or better than third party product candidates, (vi) the likelihood data will support future development of CTIM-76, and (vii) the likelihood of obtaining regulatory approval for CTIM-76. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore cannot assure you that our plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the SEC, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.

Media Contact:

Gina Mangiaracina

917-797-7904

[email protected]

Investor Relations Contact:

Jennifer Minai-Azary

Context Therapeutics

[email protected]